ENALAGEN

4) and blood pressure response.

Hypertension:

The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Enalapril is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose.

A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril.

A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Enalagen. Renal function and serum potassium should be monitored.

The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.

Heart failure/Asymptomatic left ventricular dysfunction:

In the management of symptomatic heart failure, enalapril is used in addition to diuretics and, where appropriate, digitalis or beta-blockers. 5 mg, and it should be administered under close medical supervision to determine the initial effect on the blood pressure.

In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy with enalapril in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, given in a single dose or two divided doses, as tolerated by the patient.

This dose titration is recommended to be performed over a 2 to 4 week period. The maximum dose is 40 mg daily given in two divided doses. 4). 4) because hypotension and (more rarely) consequent renal failure have been reported. In patients treated with diuretics, the dose should be reduced if possible before beginning treatment with enalapril.

The appearance of hypotension after the initial dose of enalapril does not imply that hypotension will recur during chronic therapy with enalapril and does not preclude continued use of the drug. Serum potassium and renal function also should be monitored.

Dosage in renal insufficiency:

Generally, the intervals between the administrations of enalapril should be prolonged and/or the dosage reduced. 5 mg on dialysis days* * See section

Undesirable effects reported for enalapril include:

Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare ≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and lymphatic system disorders: Uncommon: Anaemia (including aplastic and haemolytic).

Rare:

Neutropenia, decreases in haemoglobin, decreases in haematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia, lymphadenopathy, autoimmune diseases.

Endocrine disorders:

Not known: Syndrome of inappropriate antidiuretic hormone secretion (SIADH). 4).

Psychiatric disorders:

Common: Depression.

Uncommon:

Confusion, insomnia, nervousness.

Rare:

Dream abnormality, sleep disorders.

Nervous system disorders:

Very common: Dizziness.

Common:

Headache, syncope, taste alteration.

Uncommon:

Somnolence, paraesthesia, vertigo.

Eye disorders:

Very common: Blurred vision.

Ear and labyrinth disorders Uncommon:

Tinnitus.

Cardiac disorders:

Common: Chest pain, rhythm disturbances, angina pectoris, tachycardia. 4). * Incidence rates were comparable to those in the placebo and active control groups in the clinical trials.

Vascular disorders Common:

Hypotension (including orthostatic hypotension). Uncommon Flushing, orthostatic hypotension.

Rare:

Raynaud's phenomenon.

Respiratory, thoracic and mediastinal disorders:

Very common: Cough.

Common:

Dyspnoea.

Uncommon:

Rhinorrhoea, sore throat and hoarseness, bronchospasm/asthma.

Rare:

Pulmonary infiltrates, rhinitis, allergic alveolitis/eosinophilic pneumonia.

Gastrointestinal disorders:

Very common: Nausea.

Common:

Diarrhoea, abdominal pain.

Uncommon:

Ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritations, dry mouth, peptic ulcer.

Rare:

Stomatitis/aphthous ulcerations, glossitis.

Very rare:

Intestinal angioedema.

Hepatobiliary disorders:

Rare: Hepatic failure, hepatitis – either hepatocellular or cholestatic, hepatitis including necrosis, cholestasis (including jaundice). 4).

Uncommon:

Diaphoresis, pruritus, urticaria, alopecia.

Rare:

Erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma. Not known A symptom complex has been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, a positive ANA, elevated ESR, eosinophilia, and leukocytosis.

Rash, photosensitivity or other dermatologic manifestations may occur. Psoriasis, psoriasis aggravation. Musculoskeletal, connective tissue and bone disorders Uncommon Muscle cramps.

Renal and urinary disorders:

Uncommon: Renal dysfunction, renal failure, proteinuria.

Rare:

Oliguria.

Reproductive system and breast disorders:

Uncommon: Impotence.

Rare:

Gynaecomastia.

General disorders and administration site conditions:

Very common: Asthenia.

Common:

Fatigue.

Uncommon:

Malaise, fever.

Investigations:

Common: Hyperkalaemia, increases in serum creatinine.

Uncommon:

Increases in blood urea, hyponatraemia.

Rare:

Elevations of liver enzymes, elevations of serum bilirubin. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

uk/yellowcard).

4. Enalaprilat (the active metabolite) is dialysable. Dosage on non-dialysis days should be adjusted depending on the blood pressure response. 4). 2). For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response.

5 mg in patients 20 to < 50 kg and 5 mg in patients ≥ 50 kg. Enalapril is given once daily. 4). 73 m2, as no data are available. Method of administration For oral use. The absorption of enalapril is not affected by food. 1 or to any other ACE inhibitor.

6). 1) • Concomitant use with sacubitril/valsartan therapy. 5). 4 Special warnings and precautions for use Symptomatic hypotension Symptomatic hypotension is rarely seen in uncomplicated hypertensive patients. g. 8). In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed.

This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment. In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of enalapril and/or diuretic is adjusted.

Similar considerations may apply to patients with ischemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident. If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline.

A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion. In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with enalapril.

This effect is anticipated, and usually is not a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or enalapril may be necessary. Aortic or mitral valve stenosis/Hypertrophic cardiomyopathy As with all vasodilators, ACE inhibitors should be given with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.

2) and then as a function of the patient’s response to treatment. Routine monitoring of potassium and creatinine are part of normal medical practice for these patients. Renal failure has been reported in association with enalapril and has been mainly in patients with severe heart failure or underlying renal disease, including renal artery stenosis.

If recognised promptly and treated appropriately, renal failure when associated with therapy with enalapril is usually reversible. Some hypertensive patients, with no apparent pre-existing renal disease have developed increases in blood urea and creatinine when enalapril has been given concurrently with a diuretic.

Dosage reduction of enalapril and/or discontinuation of the diuretic may be required. 4 Renovascular hypertension). Renovascular hypertension There is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors.

Loss of renal function may occur with only mild changes in serum creatinine. In these patients, therapy should be initiated under close medical supervision with low doses, careful titration, and monitoring of renal function. Kidney transplantation There is no experience regarding the administration of enalapril in patients with recent kidney transplantation.

Treatment with enalapril is therefore not recommended. Hepatic failure Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death.

The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical […]

1 or to any other ACE inhibitor. 6). 1) • Concomitant use with sacubitril/valsartan therapy. 5).